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Pharmacokinetics, Acceptability and Safety of Famciclovir in Infants (1 Month to Less Than 12 Months) With Herpes Simplex Infection

NCT00448227 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2011-02-11

Study results available
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Summary

This study will evaluate the acceptability and safety of famciclovir in infants with herpes simplex infection

Conditions

  • Herpes Simplex

Interventions

DRUG

famciclovir

Administered orally as a single individualized dose between 25-200 mg based on body weight.

Sponsors & Collaborators

Principal Investigators

  • Novartis · Novartis

  • Dr. Jeffery L. Blumer · University Hospital Cased Medical Center Rainbow Babies and Children's Hospital, Cleveland, OH

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Month
Max Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2008-11-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00448227 on ClinicalTrials.gov